Halozyme, Inc v The Comptroller-General of Patents, Designs and Trade Marks

For an ingredient to qualify as an “active ingredient” under the supplementary protection certificate regime, it must have a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.

An appellate court reviewing an expert tribunal’s technical findings must respect findings reasonably open to that tribunal and must avoid “island hopping” through the evidence. A claim that an ingredient has a merely possible or plausible therapeutic effect is insufficient where the statutory requirements must actually be met.

Halozyme appealed against the Hearing Officer’s refusal of two supplementary protection certificate applications concerning trastuzumab and rituximab combined with recombinant human hyaluronidase. The central issue was whether hyaluronidase was an active ingredient or merely an excipient.

The Hearing Officer found that the marketing authorisations and supporting materials did not establish an action of hyaluronidase of its own covered by the relevant therapeutic indications. The appeal challenged that factual assessment and raised wider questions about the materials properly considered in identifying an active ingredient.

1. Appeal dismissed. The factual findings independently disposed of the appeal, so it was unnecessary to decide the wider legal question whether materials beyond the marketing authorisation, SmPC and EPAR could be considered.
2. Article 1(b) of Regulation No 469/2009, as explained in Forsgren, requires an ingredient to produce a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation. A general metabolic effect or potential therapeutic use is insufficient.
3. The Hearing Officer was entitled to find that the basic patent and scientific papers showed, at most, general or potential effects in treating cancer. They did not establish how recombinant human hyaluronidase acted in relation to the specific cancers covered by the marketing authorisations. Evidence that hyaluronidase facilitated delivery or increased the effectiveness of another drug did not satisfy the requirement of an action of its own.
4. The clinical trial did not establish that the subcutaneous formulation was superior to the intravenous formulation. It was designed to demonstrate non-inferiority, and the confidence intervals overlapped. The Hearing Officer was therefore entitled to reject the inference that hyaluronidase had an independent treatment effect.
5. On an appeal from an expert tribunal, the court reviews whether the decision was reasonably open to the tribunal. It does not conduct a rehearing or ask whether it would have reached the same conclusion. The appellant’s alternative submission that plausibility or possibility sufficed was rejected and was in any event not open on the appeal.
6. Recombinant human hyaluronidase was not an active ingredient for these applications. The Respondent’s Notice and the broader issue concerning the conclusiveness of section 2 of the SmPC were left for a suitable future case.

• High Court (Patents Court): appeal from the Hearing Officer’s decision BL O/0257/24 dated 27 March 2024; appeal dismissed.